Skip to content

The trial of the influence of circadian rhythms of melatonin by losartan

The trial of the influence of circadian rhythms of melatonin by losartan - The trial of the influence of circadian rhythms of melatonin by losartan (T-CML)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005661
Enrollment
10
Registered
2011-05-27
Start date
2011-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

The subjects take Losartan 50mg at a time, once a day, after the breakfast, for seven days.

Sponsors

Tokyo Heart Center, Dept of Clinical Pharmacology Laboratory
Lead Sponsor
Laboratory of Pharmaceutical Regulatory Science, School of Pharmacy, Nihon University SRL, Ltd. School of Medicine, Showa University Graduate school of Medicine, Tokyo University
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: The subjects are a healthy adult man. 1) The subjects are health admitted by the principal investigator (or the subinvestigators). 2) The subjects don't take antihypertensive drugs now, and there is no history of taking ARB, ACE inhibitor and a direct renin inhibitor 3) The subjects can take breakfast, lunch, and dinner during this study. 4) The subjects can avoid alcoholic beverages. 5) The subjects can use the digital automatic sphygmomanometer (made in Omron HEM-7080IC) used by home blood pressure measurement. 6) The subjects don't take the supplements or the health foods which an effect on blood pressure suggests, or are based on a mineral such as calcium during study period. 7) The subjects submit the informed consent of this study.

Exclusion criteria

Exclusion criteria: 1) The subjects with class I to class III hypertension (SBP >= 140mmHg and/or DBP >= 90mmHg) 2) The subjects prescribe beta-blockade medicine, alpha-blockade medicine, diuretic agent and oral steroid medicine, and also have to continue during this study. 3) The patients with secondary hypertension 4) The subjects with orthostatic hypotension, syncope and adynamia by orthostatic hypotension 5) The subjects with stroke, myocardial infarction and serious vascular disease to require hospitalization within six months 6) The subjects mainly do the work at night. 7) The subjects have taken a trip to foreign countries with the time difference within one week before the study starting. 8) The person with the life pattern that reverses day and night within one week before the study starting. 9) The patients who judged the principal investigator (or the subinvestigators) to be inappropriate from a medical base

Design outcomes

Primary

MeasureTime frame
The amount and the rate of change of the AUC and the peak value of the melatonin plasma level

Secondary

MeasureTime frame
The correlation between the AUC and the peak value of the melatonin plasma level and the following item 1) The amount of change of blood pressure (hospital) 2) The amount of change of blood pressure (home)

Countries

Japan

Contacts

Public ContactMotoki Arakawa

School of Pharmacy, Nihon University Laboratory of Pharmaceutical Regulatory Science

arakawa.motoki@nihon-u.ac.jp047-465-6292

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026